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Salary
$115k – $150k per year
Location
Remote (United States)
Seniority
Senior · 5+ years exp
Employment
Full-Time
Overview
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PSI

PSI (PSI CRO AG) is a privately owned, global full-service contract research organization (CRO) headquartered in Zug, Switzerland, with significant operational hubs across North and South America, Europe, Asia-Pacific, and the Middle East. Founded in 1995, PSI specializes in providing clinical trial management, monitoring, regulatory affairs, biostatistics, data management, and medical writing services for global pharmaceutical, biotechnology, and medical device companies.

Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronger study delivery.

    The Manager Operations is responsible for overseeing the operational conduct of clinical trials at

    contracted medical institutions within a defined country or region in accordance with Milestone One

    contractual obligations. The Manager Operations provides leadership to Lead Site Coordinators and

    Site Coordinators, serving as a subject matter expert and escalation point for operational issues. This

    position plays a key role in staff development, process improvement, and continuous operational

    excellence.

    SCOPE OF RESPONSIBILITIES

    • Assesses feasibility of research protocols by reviewing clinical, operational, and resource requirements and recommending suitable trials for the medical institution.

    • Monitors the progress of budget negotiations and study activation timelines to support timely site readiness.

    • Manages the team of (Lead) Study Coordinators, oversees the quality and results of their work by monitoring and follow-up of study related reports, timesheets, site trackers and other operational tools to ensure satisfactory performance of the Milestone One team.

    • Drives process improvement and standardization of clinical trial operations in alignment with ICH GCP, regulatory requirements, MO1 Controlled Documents, by contributing to the development of operational guidelines, templates, and procedures.

    • Creates a work culture environment that promotes process transparency, accountability, and continuous learning.

    • Associate degree in life sciences or similiar. Business Management degree or certification is a plus.
    • Certifications ICH GCP Training

    • Minimum 5 years of clinical on the job experience, in a leadership position at a clinical research facility or Network experience is highly preferred.

    • Knowledgeable and direct experience in the full life cycle of clinical research activities from pre-award through close out.

    • Fluent use of English

    • Proficiency in MS Office

    • Valid category B driver’s license

    • Excellent communications skills

    • Excellent management skills, experience managing remote staff preferred.

    • Effective problem solving and result oriented

    • Accountable

    • Team leadership skills

    If you want to join a developing company where people matter, you're independent and accountable, Milestone One is the right place for you.

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